Submission Details
| 510(k) Number | K133882 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2013 |
| Decision Date | April 30, 2014 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
Apr 2014
Decision
131d
Days
Class 2
Risk
About This 510(k) Submission
K133882 is an FDA 510(k) clearance for the CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO), a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by Ge Medical Systems Information Technologies, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 30, 2014, 131 days after receiving the submission on December 20, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.
Device Classification
| Product Code | DXJ — Display, Cathode-ray Tube, Medical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2450 |
Manufacturer
Ge Medical Systems Information Technologies, Inc.
Milwaukee, WI · US
ROBERT CASARSA
31 submissions
31 cleared
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